A Phase I Trial of NG-Nitro-L-Arginine (L-NNA), a Nitric Oxide Synthase Inhibitor, Given as a Single Intravenous Infusion Over 10 Minutes in Patients With Advanced Solid Tumors

Trial Information

A Phase I Trial of NG-Nitro-L-Arginine (L-NNA), a Nitric Oxide Synthase Inhibitor, Given as a Single Intravenous Infusion Over 10 Minutes in Patients With Advanced Solid Tumors

OBJECTIVES:

Primary

- To determine if there is a differential effect of NG-nitro-L-arginine (L-NNA) on tumor
and normal tissue vasculature (blood flow/volume) in patients with advanced solid
tumors in order to propose a safe recommended dose range for further evaluation.

Secondary

- To determine the correlation between plasma concentration of L-NNA and toxicity and
vascular effects.

- To further determine the effects of nitric oxide synthase (NOS) inhibition on tumor
tissue vasculature.

- To determine the pharmacokinetics of L-NNA.

- To determine the safety profile of L-NNA.

Tertiary

- To evaluate the potential pharmacodynamic effect of NOS inhibition on angiogenesis.

- To evaluate the effect of L-NNA on circulating NOS levels.

- To evaluate the correlation between expression levels of iNOS and eNOS and
vasoconstrictive effects of L-NNA in tumor tissue (where available).

OUTLINE: This is a dose-escalation study.

Patients receive a single dose of NG-nitro-L-arginine (L-NNA) IV over 10 minutes on day 1.
All patients undergo up to 6 dynamic contrast-enhanced computed tomography (DCE-CT).

- At least 4 weeks since prior radiotherapy (except for control of bone pain outside of
the investigation site for CT evaluation), immunotherapy, or chemotherapy (6 weeks
for nitrosoureas and mitomycin C)

Start Date:

Completion Date:

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